Comparison · NCT01906489-sae
Vadadustat vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Vadadustat vs Placebo: serious adverse events. Trial comparisons, record NCT01906489-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01906489-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.239 | 0.176 | 0.317 | wilson | |
| Risk in group 2 | 0.153 | 0.0875 | 0.253 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0864 | -0.0325 | 0.188 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.57 | 0.842 | 2.91 | log | |
| Odds ratio, group 1 over group 2 | 1.74 | 0.822 | 3.7 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Vadadustat than on Placebo | 11.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Vadadustat | Participants received Vadadustat 450 milligrams (mg), as 3 tablets once daily (QD) for 20 consecutive weeks. The dose of study medication was increased to a maximum of 600 mg/day or decreased to 150 mg/day based on Hgb response. Participants received an iron supplement to maintain ferritin levels. | 33 | 138 | EG000 |
| Group 2 | Placebo | Participants received matching Placebo, as 3 tablets once daily (QD) for 20 consecutive weeks. Placebo was provided as white to off-white, oval film-coated tablets for oral administration. Participants received an iron supplement to maintain ferritin levels. | 11 | 72 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the start of treatment (Day 1) up to 24 weeks.
Source ClinicalTrials.gov
Trial
- Title
- 20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
- NCT number
- NCT01906489
- Phases
- PHASE2
- Conditions
- Anemia, Chronic Kidney Disease
- Interventions
- AKB-6548, Placebo
- Lead sponsor
- Akebia Therapeutics
- Results first posted
- 2022-07-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01906489?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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